A Pilot Study Analyzing Reproductive Results After IUI Using Vitrified Human Sperm

Infertility Clinical Trial

— BIOKIBANK  

Official title:

Analysis of Reproductive Outcomes Obtained in Patients Undergoing Intrauterine Insemination With Donor Sperm Previously Vitrified - Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06243913
• Other study ID #: BIOKIBANK
• Status: Recruiting
• Start date: December 20, 2022
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Clínica EUGIN
• Contact: Mina Popovic, PhD
• Phone: 933221122
• Email: investigacion[@]eugin.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to assess the evaluate the effectiveness of vitrified donor semen in intrauterine insemination treatments.

Description:

Sperm cryopreservation is an efficient procedure widely used in fertility clinics, that provides logistical flexibility and increases the potential for success in assisted reproduction. It has been demonstrated that reproductive rates are comparable when using frozen sperm or fresh semen. However, sperm freezing using standard protocols is inevitably associated with a loss of motility, membrane integrity, and other post-thaw sperm quality parameters due to what is known as cryodamage, which involves the formation of intracellular ice crystals, osmotic shock, and dehydration.

Sperm vitrification has been recently developed as an improved alternative, where freezing occurs extremely rapidly (-20,000 ºC/min). Consequently, the formation of intracellular ice crystals is reduced, leading to improvements in sperm motility, vitality, and integrity.

However, the use of vitrified semen in fertility clinics is scarce, and no study has addressed whether vitrification could affect reproductive outcomes, such as live birth.

The aim of this study is to assess the evaluate the effectiveness of vitrified donor semen in intrauterine insemination treatments through the analysis of clinical pregnancy (primary objective) and as secondary objectives the number of progressive sperm post-thaw, percentage of progressive sperm and biochemical pregnancy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Patients undergoing Artificial Insemination with sperm from donor.

• Female partner's age < 35 years

• First IUI attempt

• Caucasian phenotype

Exclusion Criteria:

• Any adverse medical condition that may significantly affect reproductive outcomes

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• IUI with vitrified sperm from donor:
After signing the informed consent, the clinic's Matching team will assign a donor semen straw based on phenotypic characteristics, blood group, and genetic compatibility (if applicable), with the female partner. On the day of the Intrauterine Insemination (IUI), the laboratory team will thaw the assigned donor semen straw and post-thaw sperm parameters will be analyzed, including the total number of sperm with progressive motility. Subsequently, the IUI will be performed following the standard protocol.

Locations

Country	Name	City	State
Spain	Clinica EUGIN	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Clínica EUGIN

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Fetal heartbeat observed in the 7th week of gestation.	7 weeks after procedure
Secondary	Percentage of sperm progressive motility	Percentage of sperm progressive motility (% a+b) after thawing	Day of procedure
Secondary	Total number of sperm with progressive motility	Total number of sperm with progressive motility after thawing	Day of procedure
Secondary	Biochemical pregnancy rate	Positive pregnancy test	14 days after procedure